MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Erosion (1750); Therapeutic Response, Decreased (2271)

Event Date 10/11/2014

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The health care provider (hcp) via a manufacturer representative reported that the patient did well for the first several months and then about a year after receiving the device, the patient had a bad fall.A follow-up esophagogastroduodenoscopy (egd) at the time did not reveal lead migration or abnormal impedance readings.The patient was managed trying different stimulation settings, but never returned to their previous outcomes before the fall.A second egd revealed a bulge in the mucosa/submucosa of the patient's stomach where the leads were.An x-ray of the stomach also revealed that the device had moved and rotated in the pocket site.On (b)(6) 2016, the patient was sent for a complete system revision to replace the leads and stimulator.The battery was explanted as it was close to expiration and this was considered normal battery depletion.The procedure was successful and the implant impedance was 448 ohms with the new system.There was no patient death.The indication for use for this patient was gastric stimulation.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found no anomaly.Analysis of the tined leads ((b)(4)) found that the lead body was cut through and the products were segmented.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, lot/serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: lead.Product id: 4351-35, lot/serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: lead.Life threatening was removed as it was incorrectly applied.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5544722
• MDR Text Key: 41771610
• Report Number: 3004209178-2016-05954
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided; 04/20/2016; 06/14/2018
• Supplement Dates FDA Received: 05/09/2016; 09/21/2017; 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00048 YR